[pending] Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Numbers: 9903-20, 1718
Pending LLM rewrite. Source: FDA_DEVICE Z-0939-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Ophthalmic procedure packs may have incomplete seals affecting sterility.
The recalled product
- Product
- Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Numbers: 9903-20, 17188-04, 19762-03, 19203-04, 19203-04, 17957-10 Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience k
- Manufacturer
- Alcon Research LLC
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- UDI: *+H5301ALCON1CPAK10B* /9903-20 - Lot #17PJ9X
- 17188-04 - Lot # 17PJAY
- 19762-03 - Lot # 17PU09
- 19203-04- Lot # 17PMWE
- 19203-04 - Lot # 17PTXP
- 17957-10- Lot #17PTXY
Distribution
Distributed nationwide across the United States.
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